Daiichi Sankyo has announced one-year follow-up results from an analysis of 12,574 European non-valvular atrial fibrillation (NVAF) patients, mostly elderly, treated with edoxaban (Lixiana). The results from the ongoing Global ETNA-AF registry, were presented at the Great Wall International Congress of Cardiology (GW-ICC 2019 10—13 October, Beijing, China) and showed low rates of bleeding, intracranial haemorrhage (ICH) and ischaemic events during the first year of edoxaban therapy.
In the 12,574 patients from 825 sites in Europe, ISTH-defined major bleeding occurred in 125 (1.05%) patients, ICH occurred in 28 (0.23%) patients, and major GI bleeding occurred in 47 (0.39%) patients, the results stated. Ischaemic stroke occurred in 65 (0.54%) patients, transient ischaemic attack (TIA) occurred in 44 (0.37%) patients, and haemorrhagic stroke occurred in 13 (0.11%) patients.
Rates of systemic embolic events (SEE) and myocardial infarction (MI) were generally low, it was found. Per-year, SEE occurred in 13 (0.11%) patients and MI occurred in 63 (0.53%) patients. All-cause mortality occurred in 425 (3.55%) patients and cardiovascular mortality occurred in 200 (1.67%) patients. While rates of stroke, bleeding and all-cause and cardiovascular mortality increased with age, an age-related increase in ICH was not apparent and rates were low in each age group.
“In routine clinical practice, the rates of major and clinically-relevant non-major (CRNM) bleeding in elderly edoxaban-treated patients were lower than those observed in clinical trial settings. Additionally, rates of all other cardiovascular events were also low in these patients,” said Professor Raffaele De Caterina, professor of Cardiology, Institute of Cardiology at the University of Pisa, Italy. “Atrial fibrillation is the most common form of arrhythmia in patients over the age of 65, and its prevalence increases with age. As such, it is critical that we understand the safety and efficacy profile of edoxaban in elderly populations.”
The wider Global ETNA-AF programme collected data from 24,962 patients in 2,242 sites in Japan, Korea, Taiwan and Europe.
Wolfgang Zierhut, managing director, executive director Medical Affairs, Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe, said: “Findings from ETNA-AF demonstrate that Phase III efficacy and safety results from the ENGAGE AF-TIMI-48 clinical study are being confirmed in regular routine clinical care across the region.”